Strategies For Preparing For Meetings With FDA

Strategies for Preparing forMeetings with FDASusan M. Mondabaugh, Ph.D.Vice President, Regulatory AffairsHurley Consulting Associates Ltd.Chatham, NJ

Presentation Goals Overview of Types of Sponsor Meetings Sponsor Best Practices Pitfalls to Avoid

Sponsor – FDA MeetingsPDUFA 2 Defined 3 Types of Meetings: Type A Type B Needed Immediately for Otherwise StalledDevelopment ProgramPre-IND, End-of-Phase II, Pre-NDA MeetingsType C Any Other Meeting Not a Type A or Type B

Managing the Project TeamIdentifying the Need for an FDA Meeting: What Questions Do We Need Addressed? When Do We Need It? Do We Need a Face-to-Face Meeting?Is a Teleconference an Option? What is the Goal of a Meeting? What is the Desired Outcome?

Pre-IND MeetingsSpecial Considerations: First-in-Man or Phase II/III Study Design and Scope of Nonclinical Program Fast-Track Designation Request Orphan Drug Designation Request Specific Safety IssuesNot Needed for Every Drug

End of Phase II Meetings Agree on Efficacy Criteria for Phase III StudiesThat Will Be Basis of Approval Endpoints Duration of Studies Number of Studies Comparators Agree in Principle That Studies Will SupportTarget Indications Discuss Pediatric Requirements Identify Any Other Requirements

Pre - NDA Meetings Format and Content of NDA Efficacy and Safety Data Presentations Statistical Analyses Datasets and Programs Electronic or Paper Status of Pediatric Program Standard or Priority Review Special Issues

Other Meetings General Guidance Agree on FDA Protocol Comments Share Information Renegotiate Phase III ClinicalRequirements or Phase IV Commitments Specific Safety Issues Negotiate Labeling

Alleviating Meeting Stress

Best PracticesStart With the End in Mind! Ultimate Goal is the Patient Company Goals and Objectives

Meeting Request Follow Guidance Document Clearly Identify Goals and Objective ofMeeting Well-Structured Questions FDA Attendees Needed Appropriate Technical Representationand Decision Makers Be Realistic

Meeting Briefing Package Appropriate Background Information soFDA Can Address the Questions Focused Concise Brief Reviewer Friendly Allow Time for Management ReviewPrior to Submission

Meeting Preparation Identify Issues Identify Key Negotiation Points andAcceptable Fallback Positions No Presentation Unless Requested Prepare Only Key Slides That Might BeNeeded Rehearsal Logistics and Travel Time of FDA Meeting

Other Preparation Contents of Briefing Package Relevant Guidance Documents andRegulations Regulatory History of Any Issues Regulatory Playing Field (Other Drugs)

Elements for aSuccessful Meeting Role of Regulatory Affairs Prepare Responses for Likely Questions Identify Potential Speakers Be Honest Use Consultants Judiciously Designate Note Takers Summarize Key Agreements

Pitfalls to Avoid Introducing New Data Not Being Prepared Being Late Not Being Empowered to MakeCommitments Not Controlling Company Speakers orConsultants Arguing Over Policy or Regulation

Post-Meeting Debrief and Summarize Write Meeting Minutes Submit Company Minutes and Follow-upto Obtain FDA’s Review Minutes for Misunderstandings orDiscrepanciesFDA’s Version is the Official Minutes

Sponsor – FDA Meetings PDUFA 2 Defined 3 Types of Meetings: Type A Needed Immediately for Otherwise Stalled Development Program Type B Pre-IND, End-of-Phase II, Pre-NDA